topcare childrens cold and cough and runny nose

Generic: acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide

Labeler: topco associates, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name topcare childrens cold and cough and runny nose
Generic Name acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide
Labeler topco associates, llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

acetaminophen 160 mg/5mL, chlorpheniramine maleate 1 mg/5mL, dextromethorphan hydrobromide 5 mg/5mL

Manufacturer
Topco Associates, LLC

Identifiers & Regulatory

Product NDC 76162-792
Product ID 76162-792_434f84ba-ba81-a4e6-e063-6394a90ae042
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-08-12

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76162792
Hyphenated Format 76162-792

Supplemental Identifiers

RxCUI
1086750
UNII
362O9ITL9D V1Q0O9OJ9Z 9D2RTI9KYH

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name topcare childrens cold and cough and runny nose (source: ndc)
Generic Name acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/5mL
  • 1 mg/5mL
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (76162-792-04) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

76162-792-04 1 BOTTLE in 1 CARTON (76162-792-04) / 120 mL in 1 BOTTLE

Ingredients (3)

acetaminophen (160 mg/5mL) chlorpheniramine maleate (1 mg/5mL) dextromethorphan hydrobromide (5 mg/5mL)

Linked Drug Pages (1)

TOPCARE Childrens Cold and Cough and Runny Nose ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "434f84ba-ba81-a4e6-e063-6394a90ae042", "openfda": {"unii": ["362O9ITL9D", "V1Q0O9OJ9Z", "9D2RTI9KYH"], "rxcui": ["1086750"], "spl_set_id": ["8931d4ca-c599-49be-87e1-8c0598f38b77"], "manufacturer_name": ["Topco Associates, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (76162-792-04)  / 120 mL in 1 BOTTLE", "package_ndc": "76162-792-04", "marketing_start_date": "20240812"}], "brand_name": "TOPCARE Childrens Cold and Cough and Runny Nose", "product_id": "76162-792_434f84ba-ba81-a4e6-e063-6394a90ae042", "dosage_form": "SUSPENSION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "76162-792", "generic_name": "Acetaminophen, Chlorpheniramine Maleate, and Dextromethorphan Hydrobromide", "labeler_name": "Topco Associates, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TOPCARE", "brand_name_suffix": "Childrens Cold and Cough and Runny Nose", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "160 mg/5mL"}, {"name": "CHLORPHENIRAMINE MALEATE", "strength": "1 mg/5mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240812", "listing_expiration_date": "20261231"}